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Regulator OKs nation’s 1st clinical trial for ‘digital treatment’

Lee Han-soo  Published 2019.07.01  16:35  Updated 2019.07.01 16:35

공유
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The Ministry of Food and Drug Safety has approved Nunaps’ clinical trial of Nunap Vision, a digital therapeutics for improving visual disorders after brain injury. The go-ahead marks Korea’s first clinical trial of digital treatment.

A training demonstration image for Nunap Vision

Digital therapy is a third-generation therapeutic agent -- following the first-generation therapeutic compound, the second-generation therapeutic agent (antibody, protein, cell) -- which provide medical treatment through sophisticated software programs such as apps, games, virtual reality, chatbots, and artificial intelligence.

The sites of clinical trials will include the Asan Medical Center, Samsung Medical Center, Seoul National University Hospital and Seoul National University Bundang Hospital, which will aim at demonstrating the effectiveness of the Nunap Vision program.

Visual impairment due to brain damage clouds the visual field even though there is nothing wrong with the optic nerve and eyes. There are about 20,000 new patients who suffer from visual disorders after brain injury in Korea every year. However, there are no viable treatment options for the patients as of now.

“The company expects to take a leading position in the global market after completing a large-scale clinical trial,” Nunaps CEO Kwang Dong-hwa said. “The approval of the new clinical trial will become the first step in securing the local market dominance for digital therapy.”

corea022@docdocdoc.co.kr

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